MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	VNMC3131C90TU
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An valiant navion stent graft was implanted in a patient for the endovascular treatment of thoracic aortic aneurysm and to treat secondary known chronic 230mm dissection of the descending thoracic aorta.It was reported that during the index procedure the physician attempted to deploy the device landing at the innominate artery in a bovine arch.The dilated area was located just at the turn of the arch distal to the left subclavian artery (lsa).The patient had left subclavian artery (lsa) -left common carotid artery (lcca) bypass done the day previously.The plan was to cover the left subclavian artery and land proximal to the innominate artery.It was stated that the mean blood pressure during deployment was 88mmhg.It was suggested to the physician to decrease this during the deployment but it was not decreased.The stent graft delivery and placement went as planned up until the tip release was activated and the graft then deployed 2cm distal to intended landing zone and in the dilated portion of the arch.The physician was unhappy with the position of the stent graft and used an non-medtronic balloon to inflate within the stent graft and move the stent graft distally beyond the arch.The physician subsequently deployed a distal valiant navion stent graft to 1cm above the celiac artery without issue.It was reported that the physician was concerned with the proximal landing zone and an attempt was performed to use a another non-medtronic device to obtain seal.The device would not load due to a reported defect.As per the physician, cause of the event was anatomy.The arch aneurysm was gothic in nature.No additional clinical sequalae were reported and the patient is fine.
Additional Manufacturer Narrative
Analysis summary: the reported inaccurate delivery was confirmed on the films provided.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy and angiogram videos showing the real-time deployment of the device would have provided for improved analysis of the event.The most likely cause of the inaccurate delivery of the valiant navion was anatomy related due to the acutely angulated gothic aortic arch.Analysis of the returned still angiogram images did not reveal any out of specification stent graft integrity issues.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10229297
• Report Number: 9612164-2020-02415
• Device Sequence Number: 515091
• Product Code: MIH
• UDI-Device Identifier: 00763000100971
• UDI-Public: 00763000100971
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2021
• Device Model Number: VNMC3131C90TU
• Device Catalogue Number: VNMC3131C90TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR